Accuracy of Detection of Methemoglobin With Pulse Oximetry

Completed

Conditions studied: Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia

In brief

The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.

Key facts

Study ID

NCT03869840

Run by

Nonin Medical, Inc

People needed

13

Starts

2019-03-26

Expected to finish

2019-03-29

Last updated by the study team

2019-04-08

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject is male or female.
• The subject is of any racial or ethnic group.
• The subject is between 18 years and 50 years of age (self-reported).
• The subject does not have significant medical problems (self-reported).
• The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

You may not qualify if…

• Has a BMI greater than 31 (calculated from self-reported weight and height).
• Has had any relevant injury at the sensor location site (self-reported).
• Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
• Has a known respiratory condition (self-reported).
• Is currently a smoker (self-reported).
• Has a known heart or cardiovascular condition (self-reported).
• Is currently pregnant (self-reported).
• Is female and actively trying to get pregnant (self-reported).
• Has a clotting disorder (self-reported).
• Has Raynaud's Disease (self-reported).
• Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia) (self-reported).
• The subject has a COHb greater than 3% or MetHb greater than 2% (based on the first blood sample analysis).
• Has taken blood thinners or medication with aspirin within the last 24 hours (self-reported).
• Has unacceptable collateral circulation from the ulnar artery (based on exam).
• Has donated more than 300 mL of blood within one month prior to start of study (self-reported).
• Is unwilling or unable to provide written informed consent to participate in the study.
• Is unwilling or unable to comply with the study procedures for the primary objectives.
• Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.